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Denmark Leads The Way On Speeding Up Approvals For Drug/IVD Combination Trials

 
• By Vibha Sharma

While an EU-level project is underway to address delays to drug trials that are conducted in combination with IVD performance studies, Denmark has streamlined its processes to address the issue at the national level.

forefront of tubes in a rack used for analysis
IVDs are commonly used in clinical trials to detect a disease or other conditions • Source: Shutterstock

The Danish Medicines Agency has launched a new coordinated process that allows sponsors to apply for the simultaneous approval of so-called combined studies that involve a clinical trial of a medicinal product in parallel with the performance study of an in vitro diagnostic (IVD).

The DMA’s new process aims to address the ongoing issues facing sponsors of combined studies, who must seek regulatory...

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